On March 31, 2020 Shanghai Junshi Biosciences reported it has been approved to list on the Shanghai STAR Exchange. In late 2018, Junshi completed a $394 million IPO in Hong Kong, and the company’s shares have climbed about 50% in the 15 months since then (Press release, Shanghai Junshi Bioscience, MAR 31, 2020, View Source [SID1234556060]). Just after the Hong Kong IPO, Junshi was approved to market Tuoyi, the first China-developed anti-PD-1 drug as a second-line treatment for melanoma. It is the first domestic PD-1 approved in China. Tuoyi produced $110 million in revenues during 2019.

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On March 31 2020 Shanghai Fosun Pharmaceutical (Group) Co., Ltd ("Fosun Pharma"; Stock Code: 600196.SH, 02196.HK), a leading healthcare group in China, reported its annual results for the year 2019 ("the reporting period") (Press release, Fosun, MAR 31, 2020, View Source [SID1234556058]).

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During the reporting period:

The revenue increased by 14.72% as compared to 2018 to RMB 28,585 million;
The net profit amounted to RMB 3,744 million, representing a respective increase of 23.96%;
The net profit attributable to shareholders of the listed company amounted to RMB 3,322 million, representing a respective increase of 22.66%.
The cash flow from operating activities continued to rise. Net cash flow from operating activities amounted to RMB 3,222 million, representing an increase of 9.23% as compared to 2018.
Wu Yifang, President and CEO of Fosun Pharma, expressed that "2019 marks a crucial period for the pharmaceutical industry to experience comprehensive transformation. On the basis of properly carrying out the existing business and industrial upgrade, Fosun Pharma is firmly committed to the path of innovation and international development. Focusing on unmet medical needs, it continuously improved its product competitiveness and brand strength, persistently enhanced its capability of innovation, integration and international development, and conducted efficient operations, thereby maintaining the balanced growth of its principal businesses. We believe that our efforts in innovation will help Fosun Pharma realize its innovation transformation. The steady international-oriented development will make us more competitive internationally in terms of operation standards and market expansion."

Revenue for core products grew steadily and deeply cultivated the whole-industry chain of healthcare industry

The business areas of Fosun Pharma cover the whole-industry chain of pharmaceutical and healthcare. Its business development is based on China while Fosun Pharma actively conducts global layouts. In 2019, the core business of Fosun Pharma, pharmaceutical manufacturing and R&D segment, maintained stable growth and recorded segment operating revenue of RMB 21,766 million, an increase by 16.51% as compared to 2018.

After years of professional operations, Fosun Pharma owns several advantageous products in the metabolism and alimentary system, anti-tumor therapeutic area, anti-infection therapeutic area, the central nervous system, cardiovascular system, blood system and other areas. In 2019, Rituximab injection (Han Li Kang) was launched as the first biosimilar that was independently developed in PRC. The number of preparation products of Fosun Pharma with annual sales revenue of over RMB100 million rose to 35, among which ten products reported annual sales revenue of over RMB500 million. The sales growth volume of core products, febuxostat tablets (You Li Tong), pitavastatin calcium tablets (Bang Zhi) and enoxaparin sodium injection recorded growth of 105%, 113% and 57%, respectively.

By virtue of endogenous operations and epitaxial M&A, the medical devices and medical diagnosis segment achieved favorable growth and recorded operating income of RMB 3,736 million in 2019, an increase of 2.66% over 2018, 28.5% YoY increase on the same basis. The existing medical devices and products of Fosun Pharma, including medical laser equipment for aesthetic treatments, high-end medical emergency ambulance and surgical robots, ranked top in the segmented industry and market. In particular. Da Vinci surgical robotic system, created by the joint venture Intuitive Fosun, is the world’s only minimally invasive endoscopic surgery robot product licensed by both FDA and China National Medical Products Administration. It recorded a rapid increase in its installation and number of surgeries performed, with 60 Da Vinci surgical robotic system installed and over 40,000 surgeries performed in Chinese Mainland and Hong Kong SAR in 2019. A rapid increase in sales recorded in HPV diagnostic reagent and genetic testing reagent for Thalassemias.

The revenue from the Healthcare services segment amounted to recorded operating income of RMB 3,040 million, representing an increase of an increase of 18.61% as compared to 2018. Fosun Pharma always adheres to the guideline of "Valuing Discipline Development and Offering Quality Medical Services" for medical services. Fosun Pharma had completed a strategic deployment of healthcare services in specialty and general hospitals with the Pearl River Delta Greater Bay Area, Yangtze River Delta and Huaihai Economic Zone being the regional focus for healthcare services. As of the end of 2019, over 10 medical institutions controlled by the Group, with a total of 4,328 authorized beds available for the public. In addition, Fosun Pharma proactively developed new medical services and products based on the Internet and constructed a service network from communities to hospitals. During the reporting period, Foshan Chancheng Hospital obtained the first internet hospital license within the Guangdong Province private hospital system.

Boost investment in innovation and R&D to build an international R&D platform

Fosun Pharma regarded innovation and R&D as the core-driving factor of development and continued to enhance its R&D expenditures. In 2019, the R&D expenses amounted to RMB 3,463 million, representing an increase of 38.15% as compared to 2018; the R&D expenses reached RMB 2,041 million, up by 37.97%. Specifically, R&D investment in the pharmaceutical manufacturing business was RMB 3,131 million, up by 39.12% and accounting for 14.38% among the revenue of the pharmaceutical manufacturing segment.

Fosun Pharma continuously optimized its pharmaceutical R&D system of "Combination of integrates biosimilars and innovative drugs", conducted layouts in China, the US, India and other places, developed efficient small-molecule innovative drugs platform, high-value generic drugs platform, biologics platform and cell-therapy platform, and has formed a globally interactive R&D system as well as strong R&D capability.

As of the end of the reporting period, Fosun Pharma had 264 pipeline innovative drugs, generic drugs, biosimilars and consistency evaluation projects of generic drugs (including 19 small molecular innovative drugs, 12 biopharmaceutical innovative drugs, 21 biosimilars, 133 generic drugs of international standards, 49 consistency evaluation projects, 2 traditional Chinese medicine drugs, 28 external projects (including 8 imported innovative drugs and 20 generic drugs were introduced)).

In 2019, Fosun Pharma focused on increasing its R&D investment in small molecular innovative drugs and monoclonal antibody biopharmaceutical innovative drugs and biosimilars, and CAR-T cell drugs, and systematically carried forward the introduction and registration of drug approvals and the consistency evaluation of generic drugs.

As of the end of 2019, Fosun Pharma has obtained approval for clinical trial in Mainland China on 9 small molecule innovative products (including 1 improved new drug) and 9 indications; as well as approval for overseas clinical trials for 3 small molecule innovative drugs and 3 indications. In particular, ORIN1001 had launched phase I clinical trials in the U.S. and recognized by the U.S. Food and Drug Admistration (”U.S. FDA”) under the Fast Track Development Program. In 2019, rituximab injection (Han Li Kang), the first domestic biosimilar, was approved for sales in Chinese Mainland; 2 monoclonal antibody biosimilars (Trastuzumab for injection and Adalimumab solution injection) were accepted for new drug application and included in the priority review procedure in Chinese Mainland; and 12 monoclonal antibody products and 8 combination therapies had launched more than 20 clinical trials worldwide;Axicabtagene Ciloleucel (code FKC876, i.e. anti-human CD19 CAR-T cell injection) of Fosun Kite, a joint venture, completed the bridging clinical trial of the Product for the treatment of adult patients with relapsed and refractory large B-cell lymphoma in Chinese Mainland and commenced clinical trials in Chinese Mainland and was granted priority review status for the launch and registration of drugs in March 2020.

Persist with international development for greater global competitiveness

In addition to constant innovation, Fosun Pharma furthered its international development strategy, with the proportion of overseas revenue rising to 23.17%. Revenue of an equivalent of RMB 6,622 million was recorded in other countries or regions, representing an increase of 12.12% as compared to 2018. Particularly, the core enterprise Gland Pharma’s net profit increased by 52.2% year-on year during the Reporting Period. During the reporting period, totally 15 generic drug products were approved by the US FDA for sales in the market. As of the announcement date, Gland Pharma for a total of 2 imported products for registration and marketing authorization, and applications for import registration and clinical trials for 4 products.

By centering on the unsatisfied healthcare needs, Fosun Pharma connected excellent scientist teams, leading technology and high-value products across the globe through permitted introduction, deep incubation, risk investment and other diversified and multi-tiered cooperation modes, so as to promote the global development, transformation and implementation of innovative technology and products.

In 2019, in order to further enrich the product lines, Fosun Pharma engaged in cooperation with ReNeuron Limited, a global leader in cell therapy, and imported cell therapy products targeting post-stroke disability and retinitis pigmentosa to advance the development of the stem cell platform. Fosun Pharma was authorized by MimiVax LLC to exclusively develop and commercialize SurVaxM, an immunotherapy product targeting recurrent glioblastoma. In addition, Fosun Pharma has accelerated the clinical trials and launch of permitted imported drugs Avatrombopag tablets and Tenapanor tablets. In terms of international expansion, Fosun Pharma not only established subsidiaries and developed its operating capability in mature markets such as the US and Europe, but developed markets and production capacity through self-development and M&A in emerging markets such as Africa and India. As at the end of 2019, Fosun Pharma has built a marketing team consisting of nearly 5,300 people, including nearly 1,000 overseas pharmaceutical, medical equipment marketing team. In oversea market, artemisinin-based antimalarial products are highly recognized in the African market.

On March 31, 2020 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX, TSX-V: EPI), a pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to evaluate its lead clinical candidate, EPI-7386, in a Phase 1 clinical study for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) (Press release, ESSA, MAR 31, 2020, View Source [SID1234556057]).

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"We believe that EPI-7386 has the potential to be an important new therapy for men with prostate cancer. All of the preclinical data accumulated to date leads us to believe that it will be an active agent with a good PK profile," commented David R. Parkinson, MD, CEO of ESSA. "We remain focused on conducting a clinical trial of this unique inhibitor of the N-terminal domain of the androgen receptor in adult male patients with mCRPC resistant to standard of care treatments. We are pleased that we were able to file the IND as planned. This is a significant milestone for the Company and we look forward to beginning clinical testing of EPI-7386 in patients as soon as possible."

The Company also provided a business update as the COVID-19 situation rapidly evolves. To date, the global coronavirus outbreak has not had a material impact on the Company’s business operations. At present, ESSA does not anticipate changes to planned achievement of key clinical milestones in calendar year 2020, but is continuing to monitor the situation.

Business Updates:

We remain on track to commence the monotherapy clinical study of EPI-7386 in mCRPC patients resistant to standard of care treatments in Q2 2020.

Enrollment will be approximately 18 patients at multiple US and Canadian medical institutions in a standard 3+3 trial design with up to 10 additional patients enrolled in the dose expansion cohort.

Clinical sites are being finalized and we are preparing for clinical trial initiation. We are working with our contract research organization ("CRO") to prepare for clinical trial initiation, despite the current limitations on travel. We will also augment our trial risk management plan including mitigation strategies to deal with clinical trial sites that may be impacted by the COVID-19 situation. This plan will incorporate the latest FDA guidance regarding clinical trial conduct during the COVID-19 pandemic.

Although our in-person lab activities are affected by COVID-19, we have conducted extensive gene expression studies demonstrating differentiation of our N-terminal domain (NTD) inhibition mechanism from ligand binding domain (LBD) inhibition by anti-androgens as well as the unique quantitative and qualitative effects of the combination of NTD and LBD androgen receptor inhibition. The full analysis of these results will be presented at a future scientific meeting.

The Company ended December 31, 2019 with $45.9 million cash, which we believe provides operating funds through fiscal year end 2022 (September 30) and will allow ESSA to complete the Phase 1 monotherapy dose-escalation study, an expansion phase to that study, and a combination study of EPI-7386 with currently utilized antiandrogens in metastatic prostate cancer patients with earlier stages of the disease.

On March 31, 2020 AbbVie (NYSE: ABBV ), a global research-based biopharmaceutical company, reported that the clinical trial VIALE-A (M15-656) of VENCLEXTA (venetoclax) in combination with azacitidine versus the azacitidine combination with placebo achieved its two main primary objectives: statistically significant improvement in overall survival and compound complete remission rate for patients with prior treatment AML and ineligible for treatment with intensive chemotherapy (Press release, AbbVie, MAR 31, 2020, View Source;842586695.html [SID1234556055]). The complete results will be submitted to the United States regulatory agency, FDA ( Food and Drug Administration ), and to global health authorities, and will also be presented at medical congresses or published in specialized journals.

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"In the past three decades, few options have emerged for AML patients who cannot receive or tolerate intensive chemotherapy or bone marrow transplantation," said physician Neil Gallagher , Ph.D., AbbVie medical director and vice president of development . "The positive results of the VIALE-A study support the clinical benefit of the combination venetoclax plus azacytidine in AML patients who are not eligible for intensive chemotherapy and reflect our ongoing commitment to transforming the standards of care for patients with hematological neoplasms."

AML is one of the most aggressive and difficult to treat blood cancers, with a very low survival rate 1,2 . Despite advances in available therapies and care, the 5-year survival rate for patients diagnosed with AML is approximately 28% 3 . AML generally worsens rapidly and, due to age and existing comorbidities, not all patients are eligible for intensive chemotherapy 4 . AML is the most common acute leukemia in the world 5 .

It is estimated that 160,000 people are currently living with the disease globally, with an incidence rate of 103 new cases per 100,000 people 5

The Phase 3 VIALE-A study evaluated the efficacy and safety of venetoclax in combination with azacitidine compared to the placebo plus azacitidine combination. The study achieved its two primary outcomes of overall survival and complete composite remission (CR + CRi). The observed safety profile is generally consistent with the known safety profile of venetoclax with azacytidine, as seen in previous Phase 1/2 studies and the known safety profiles of the two drugs.

In November 2018, AbbVie received rapid US approval of VENCLEXTA in combination with azacytidine, decitabine or low-dose cytarabine for the treatment of newly diagnosed AML in adults aged 75 years or older, or with comorbidities that prevent the use of chemotherapy. intensive induction based on Phase 1/2 studies. Approval was also granted by regulatory authorities in Mexico, Israel , Puerto Rico, Peru , Brazil, Russia, Argentina , Guatemala , Uruguay, Lebanon, Bahrain , Kazakhstan, Panama, Saudi Arabia, Taiwan , Australia, Qatar and the United Arab Emirates.

VENCLEXTA is being developed by AbbVie and Roche. It is marketed jointly by AbbVie and Genentech, a member of the Roche Group , in the USA, and by AbbVie outside the USA.

About the VIALE-A Phase 3 Study (M15-656)

A total of 443 patients with AML without prior treatment were included in the study and 433 were randomized to the Phase 3 VIALE-A, double-blind, placebo-controlled study. The study was developed to assess the efficacy and safety of venetoclax in combination with azacitidine (n = 287) compared to placebo in combination with azacitidine (n = 146). 6

About VENCLEXTA (venetoclax)

VENCLEXTA (venetoclax) is the first drug in the class to selectively inhibit BCL-2. In some types of cancer, BCL-2 prevents cancer cells from going through the natural process of death or self-destruction, called apoptosis. VENCLEXTA targets the BCL-2 protein and, through its mechanism of action, helps to restore the apoptosis process.

VENCLEXTA is being developed by AbbVie and Roche. It is marketed jointly by AbbVie and Genentech, a member of the Roche Group , in the USA and by AbbVie outside the USA. Together, the companies are committed to BCL-2 research and clinical studies of venetoclax for the treatment of various types of blood and other cancers. VENCLEXTA is approved in more than 50 countries, including the United States and Brazil.

About AbbVie in Oncology

At AbbVie, we strive to discover and develop drugs that provide transformative improvement in cancer treatment, uniquely combining our deep knowledge in key areas of biology with advanced technologies, and by working together with our partners – scientists, clinical experts, peers from industry, patient support groups and patients. We remain focused on generating these transformative advances in the treatment of some of the most complex and aggressive types of cancer. AbbVie’s oncology portfolio consists of drugs already in use and new molecules being evaluated worldwide, through more than 300 clinical studies and more than 20 different types of tumors. For more information, visit www.abbvie.com/oncology.

On March 31, 2020 IONpath, Inc. reported that it has jointly produced with Bristol Myers Squibb an article entitled Multiplexed Ion Beam Imaging (MIBI) for Characterization of the Tumor Microenvironment Across Tumor Types (Multiplexed ionic ray images to characterize the tumor microenvironment in different types of tumors) for the journal Laboratory Investigation of the scientific journal Nature (Press release, IONpath, MAR 31, 2020, View Source [SID1234556054]).

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The ability to understand all cells present within a tumor by differentiating different cell types at the same time in a single tissue section has been limited by the technology available. In the article, the authors demonstrate how Multiplexed Ion Beam Imaging (MIBI ) technology (multiplexed ion beam images) is able to detail the characteristics of a wide variety of tumor types by providing identification of the cell phenotype along with the analysis of their spatial relationships. For this collaboration, Bristol Myers Squibb provided samples of 50 tumor biopsies to IONpath, which were simultaneously marked with a panel of 15 antibodies, each labeled with a specific metal isotope. The highly detailed mapping of the tumor microenvironment generated an immunological profile(fig. 1) and a spatial organization (fig. 2) through a multi-step process that segmented the sample to the individual cell.

Such information was collected as an exercise to observe the characteristics of the samples in question. However, the implications of this new level of tumor mapping at the cellular level can be far-reaching. Scientists and drug developers can now measure the proximity between immune cells and cancer cells. Within the same sample, they can also measure protein expression levels of potential drug targets and other variables associated with the response to certain therapies, such as those that target immunological checkpoints.

"IONpath’s mission is to enable medical discovery, specifically in the field of immuno-oncology, by characterizing the tumor microenvironment down to the cellular level," said Dr. Jessica Finn , director of pathology and one of the authors of the article. She added that "examining these detailed and interrelated structures is a difficult but important job in the fight to cure certain types of cancer."

Exemplifying how this mission for IONpath can impact on real-world decisions, the study demonstrated the possibilities for calculating distances between different cell subsets, including tumor and immune cells, as well as subsets of immune cells that express PD-1 and PD -L1. Further studies in this area can be designed to support better results in the field of immuno-oncology.